Amit Sohagia, MD received ACG’s Outstanding Poster Presenter Award for TIF 2.0 procedure poster

REDMOND, Wash. – EndoGastric®Solutions today announced the presentation of three posters at the American College of Gastroenterology (ACG) 2018 Annual Scientific Meeting and Postgraduate Course, highlighting the safety and efficacy of Transoral Incisionless Fundoplication (TIF) 2.0 procedure in the treatment of gastroesophageal reflux disease (GERD). TIF 2.0 procedure is a minimally invasive and endoscopic intervention that enables anatomical correction of the gastric valve without incisions or attendant complications associated with laparoscopic surgical fundoplication. The  2018 annual meeting was held October 5 – 10 in Philadelphia, PA.

Amit Sohagia, MD, a gastroenterologist at Easton Hospital, received the ACG’s Outstanding Poster Presenter Award for an abstract titled “Transoral Incisionless Fundoplication: Effectiveness in Improving Typical and Atypical Symptoms of Gastroesophageal Reflux Disease Incompletely Controlled with Medical Therapy.”

“The results of our study add to the robust foundation of data demonstrating that the TIF procedure improves quality of life in patients by effectively addressing both typical and atypical GERD symptoms.” Amit Sohagia, MD, Easton Hospital
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“With the prevalence of GERD increasing worldwide, a growing number of patients are living with reflux symptoms that reduce their quality of life and increase their risk of cancer,” said Dr. Sohagia. “Patients refractory to medical therapy may benefit from surgical intervention, but traditional invasive procedures are associated with a variety of adverse events. The results of our study add to the robust foundation of data demonstrating that the TIF procedure improves quality of life in patients by effectively addressing both typical and atypical GERD symptoms.”

Dr. Sohagia presented the results of a prospective study conducted in 41 patients with long-standing history of GERD refractory to acid suppressant medications (proton pump inhibitors [PPIs] or histamine antagonists [H2 blockers]) who underwent the TIF procedure. The primary outcome was patient satisfaction as determined by pre- and post-TIF procedure GERD Health Related Quality of Life Questionnaires (GERD-HRQL) and Reflux Symptom Index (RSI) scores, along with the reduction in the use of PPIs or H2 blockers. At median follow up of nine months, significant improvements were reported for GERD-HRQL and RSI and for symptoms of heartburn, dysphagia and regurgitation (p= 0.0001 for all assessments except for dysphagia, which had a p value of 0.006). At short-term follow up, TIF procedure eliminated the need for PPI therapy in the majority of patients. Patients who initiated PPI or H2 blocker therapy after the TIF procedure also had significant improvements in pre- and post-TIF procedure scores on GERD-HRQL and RSI (p = 0.002 and 0.047, respectively).

The two other posters presented at ACG 2018 were:

  • “Efficacy and Safety of Trans-Oral Incisionless Fundoplication Performed by Gastroenterologists,” which demonstrated that gastroenterologists trained in TIF procedure can safely perform the procedure in the endoscopy suite. This may save time and healthcare resources by reducing operating room (OR) use. The study also found that TIF procedure performed by gastroenterologists effectively improved HRQL in patients with symptomatic GERD. Presented by Ali Raza, MD1, Marc Catalano, MD1, Erik F. Rahimi, MD1, Hani A Zamil, MD2, Bijun S. Kannadath, MBBS, MS3, Julie Guider, MD1, Reena V. Chokshi, MD4, Brooks D. Cash, MD, FACG1, Todd Wilson, MD1, Erik Wilson, MD1, Nirav Thosani, MD2;1University of Texas Health Science Center at Houston, Houston, TX; 2University of Texas Health Science Center at Houston / McGovern Medical School, Houston, TX; 3University of Arizona College of Medicine, Phoenix, AZ; 4UT Health – McGovern Medical School, Houston, TX
  • “Transoral Incisionless Fundoplication in a Patient with Dysphagia from Peptic Stricture,” which showed that TIF procedure can be used to reduce esophageal acid exposure and prevent stricture recurrence in a patient with dysphagia due to recurrent peptic stricture. Presented by Zain Iqbal Memon, DO, David Dicaprio, DO, Patrick Okolo, MD; Northwell Health Lenox Hill Hospital, New York, NY.

“The data presented at ACG 2018 continues to demonstrate that TIF 2.0 procedure is a safe and effective approach to treating GERD in a variety of patient populations and can be performed in the operating room or the endoscopy suite,” said Skip Baldino, President and CEO of EndoGastric Solutions. “These results highlight the clinical benefits that the TIF 2.0 procedure provides to patients and the workflow flexibility that it affords physicians and care centers. We congratulate Dr. Sohagia on receiving the Outstanding Poster Presenter Award, and for his continued efforts to help the GERD patients he serves.”

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About GERD
Gastroesophageal reflux disease (GERD) is a common gastrointestinal disease that affects nearly 20 percent of the U.S. population. It is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to reflux (wash backwards) into the esophagus, causing heartburn and possible injury to the esophageal lining. In the United States (U.S.), GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits. Some patients may have mild or moderate symptoms of GERD, while others have more severe manifestations causing chronic heartburn, asthma, chronic cough, and hoarse voice or chest pain. Left untreated, GERD can develop into a pre-cancerous condition called Barrett’s esophagus, which is a precursor for esophageal cancer. The first treatment recommendation for patients with GERD is to make lifestyle changes (e.g., diet, scheduled eating times and sleeping positions). Proton pump inhibitor (PPI) medications are commonly used to treat GERD, but there are a variety of health complications associated with long-term dependency on PPIs, and more than 10 million Americans are refractory to PPI therapy and may opt for surgery.

About Transoral Incisionless Fundoplication (TIF® 2.0 procedure) for Reflux
The TIF 2.0 procedure enables an incisionless approach to fundoplication in which a device is inserted through the mouth, down the esophagus and into the upper portion of the stomach. This approach offers patients looking for an alternative to traditional surgery an effective treatment option to correct the underlying cause of GERD. Based on clinical studies, most patients stopped using daily medications to control their symptoms and had their esophageal inflammation (esophagitis) eliminated up to five years after the TIF 2.0 procedure. Additionally, clinical results have demonstrated that concomitant laparoscopic hiatal hernia repair (LHHR) immediately followed by TIF 2.0 procedure is safe and effective in patients requiring repair of both anatomical defects.

Over 25,000 TIF procedures have been performed worldwide. More than 140 peer-reviewed papers have consistently documented the sustained improved clinical outcomes and exemplary safety profile the TIF procedure provides to patients suffering from GERD. For more information, please visit www.GERDHelp.com.

About Reimbursement
With the support of clinical societies, commercial and federal insurance providers, representing more than 100 million lives, have recognized the value of the TIF 2.0 procedure through recently expanded coverage policies. The TIF 2.0 procedure is a covered benefit for all Medicare beneficiaries across the country.

For the TIF 2.0 procedure, physicians and hospitals can reference CPT Code 43210 EGD esophagogastric fundoplasty. CPT is a registered trademark of the American Medical Association.

About EsophyX® Technology
The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids from refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope, and enables creation of a 3 cm, 270° esophagogastric fundoplication. The U.S. Food and Drug Administration cleared the original EsophyX device in 2007. The evolving technology, including the latest iteration EsophyX Z+, launched in 2017, enables surgeons and gastroenterologists to use a wide selection of endoscopes to treat the underlying anatomical cause of GERD.

Indications
The EsophyX device, with SerosaFuse® fasteners and accessories, is indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. It is indicated for the treatment of symptomatic chronic GERD in patients who require and respond to pharmacological therapy. The device is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2 cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2 cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2 cm or less.

About EndoGastric Solutions®
Based in Redmond, Washington, EndoGastric Solutions, Inc. (www.endogastricsolutions.com), is a medical device company developing and commercializing innovative, evidence-based, incisionless surgical technology for the treatment of GERD. EGS has combined the most advanced concepts in gastroenterology and surgery to develop products and procedures to treat gastrointestinal diseases, including the TIF 2.0 procedure—a minimally invasive solution that addresses a significant unmet clinical need. Join the conversation on Twitter: @GERDHelp Facebook: GERDHelp and LinkedIn: EndoGastric Solutions.

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Contact:
Ted Stephens
EndoGastric Solutions, Inc.
Phone: +1 513-312-9161
tstephens@endogastricsolutions.com

Erich Sandoval
Lazar Partners
Phone: +1 917-497-2867
esandoval@lazarpartners.com